Amatuximab in Treating Patients with Advanced Pancreatic, Mesothelioma, Ovarian, or Non-Small Cell Lung Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
No phase specifiedBiomarker/Laboratory analysis, TreatmentActive18 and over11-C-0212
NCI-2013-01497, 009-006, 110212, P10769, NCT01413451

Trial Description

Summary

This pilot clinical trial studies amatuximab in treating patients with advanced pancreatic, mesothelioma, ovarian, or non-small cell lung cancer. Monoclonal antibodies, such as amatuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the biodistribution of 111Indium (111In)-labeled MORAb-009 (amatuximab) in tumor and nontumor tissues in subjects with advanced mesothelin over-expressing cancers (pancreatic, mesothelioma, ovarian, or non-small cell lung cancer [NSCLC]).

SECONDARY OBJECTIVES:

I. To determine the pharmacokinetic (PK) parameters of the indium labeled amatuximab.

II. To explore the uptake of Indium-CHX-A amatuximab with mesothelin tumor expression as determined by immunohistochemistry (IHC).

III. To tabulate the occurrence of human antichimeric antibodies (HACA).

IV. To correlate shed serum mesothelin to imaging obtained after antibody administration.

OUTLINE:

Patients receive amatuximab intravenously (IV) over 15 minutes.

After completion of study treatment, patients are followed up at 2 weeks and 30 days.

Eligibility Criteria

Inclusion Criteria:

Histologically-confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma,

mesothelin-positive ovarian cancer, or NSCLC; a new biopsy is not required; the diagnostic biopsy sample will be sufficient; IHC confirmation of mesothelin positivity is not necessary for pancreatic adenocarcinoma and mesothelioma; mesothelin expression in ovarian cancer and NSCLC will be tested by IHC, and any degree of positivity (1+, 2+, or 3+) will be accepted

Subjects are required to have measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is >= 1.5 cm, as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST)

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Female subjects of childbearing potential and all male subjects are required to consent to use a medically acceptable method of contraception throughout the study period and for 30 days after amatuximab administration; a barrier method of contraception is required

Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

Platelet count >= 75 x 10^9/L

Hemoglobin >= 9 g/dL

Serum bilirubin =< 1.5 mg/dL

Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN) (=< 5 x ULN acceptable for pancreatic subjects with known liver metastasis only)

Alanine transaminase (ALT) =< 3 x ULN (=< 5 x ULN acceptable for pancreatic subjects with known liver metastasis only)

Alkaline phosphatase =< 5 x ULN

Serum creatinine =< 1.5 mg/dL

Subjects are required to be willing and able to provide written informed consent

Exclusion Criteria:

Known allergy or hypersensitivity to monoclonal antibodies

Prior treatment with MORAb-009

Prior treatment with SS1(dsFv)PE38 (SS1P)

Known brain metastases

Known prosthetic devices that would prohibit imaging of lesion of interest due to radiographic artifact

Evidence of other active malignancy requiring treatment

Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months)

Electrocardiogram (ECG) demonstrating clinically significant arrhythmias; subjects with chronic atrial

arrhythmia, (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia), are eligible

Active serious systemic disease, including active bacterial or fungal infection within 2 weeks before study entry

Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection

Treatment within 3 months with immunomodulatory therapy (e.g., interferons, immunoglobulin therapy, interleukin 1 receptor antagonist or systemic corticosteroids); short-term systemic corticosteroids or topical or intra-articular steroids are acceptable, at the discretion of the Investigator

Chemotherapy, biologic therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab

Breastfeeding, pregnant, or likely to become pregnant during the study

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NCI - Center for Cancer Research

  • National Cancer Institute
Raffit Hassan, Principal Investigator

Trial Sites

U.S.A.

Maryland
Bethesda

National Institutes of Health Clinical Center

Raffit Hassan
Ph: 301-451-8742
Email: hassanr@mail.nih.gov

Raffit Hassan
Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01413451

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.